SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)
FDA 510(k) clearance K915363 · decided 1993-07-28
Clearance details
- K-number
- K915363
- Device name
- SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)
- Applicant
- 3M Health Care, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1991-11-27
- Decision date
- 1993-07-28
- Days to decision
- 609 days
- Clearance type
- Traditional
- Product code
- KFM
- Device class
- 2
- Regulation number
- 870.4360
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ann Arbor, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch 3M Health Care
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sarns Centrifugal Pump (without X-coating), catalog 164275, packaged in 8 piece shelf boxe recall (Z-0545-2010) | Terumo Cardiovascular Systems Corporation | 2009-12-17 |